ISSN:0363-9045    

DOI:10.3109/03639048409039053

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639048409039054

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

摘要:

AbstractThe stability of solids and semisolid dosage forms is characterized by either being a stability of the drug per se, in which case one of the phases of Prout-Tompkins equation holds (leading to either pseudo-first or pseudo-zero order reactions) or by being an interaction. For interactions with water in small amounts, or with trace reactants, an equilibrium is reached. When larger amounts of water are present, then Leeson-Mattocks kinetics hold, and a pseudo-zero order reaction applies.

ISSN:0363-9045    

DOI:10.3109/03639048409039055

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639048409039056

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

摘要:

AbstractStability-indicating analytical methods are developed to monitor the stability of pharmaceutical dosage forms during the investigational phase of drug development, and, once the drug is marketed, for the ongoing stability studies which must be conducted. The development of these methods for pharmaceutical dosage forms forms can be approached from several avenues. Methods can be developed which measure the amount of drug remaining, the amount of drug lost (or the appearance of degradation products), or both.Traditionally, the analytical methods used to monitor the stability of dosage forms have involved a generally non-specific spectrophotometric or titrimetric procedure for the assay of the active coupled with thin layer chromatography for the estimation of impurities and degradation products. In the last five years, this approach has changed dramatically. Currently, the method of choice for the quantitation of the active and degradation products is rapidly becoming high performance liquid chromatography. This method has obvious advantages since it both separates and measures and it lends itself well to automation. The disadvantages are that, in the absence of automation, the technique can be time-consuming, it is by no means universal, and it is relatively expensive. Recent advances in column technology have reduced some separation times to seconds and, in the next few years, this technique may find even greater utility.HPLC, however, is not the only way to go. Other chromatographic methods still find a place, particularly gas chromatography when the stability of the component of interest does not pose a problem and thin layer chromatography for the rapid determination of degradation products. Other methods may also be used, including electrometric, e.g., polarography, and spectrophotometric, e.g., fluorimetry or NMR. The choice of an appropriate method must depend on both a scientific and practical evaluation of the drug and its dosage form.Once an analytical method is chosen, the most important aspect of the development of a stability-indicating procedure is method validation. Validation should include evaluation of the following parameters: specificity, linearity, precision, accuracy, sensitivity, and ruggedness.There are many other aspects to stability that could also be considered, e.g., the stability of the bulk drug and physical and organoleptic changes in a dosage form. These should be part of a separate discussion. It very often happens that, during the course of product development, analytical methods evolve. As more is learned about the drug and its dosage form, methods can be refined and revised.

ISSN:0363-9045    

DOI:10.3109/03639048409039057

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639048409039058

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

摘要:

AbstractThe theme of this presentation is based on the premise that, despite the existence of differences in specific stability testing protocols between different types of products of the same manufacturer and between similar products of different manufacturers, it is possible to generalize somewhat and to identify elements common to any stability testing program. In terms of stability testing, a drug product may be viewed as passing through a series of distinct, identifiable stages in its development, which represents a progression of stability testing with product maturation. Within this progression, a range of testing protocols, methods and mathematical models may be utilized with each successive program designed to augment the data base of the product and thereby strengthen and expand the conclusions reached during each preceding phase. Differing types and amounts of information are sought at each stage which are important to the assignment of an expiration date, thus giving rise to widely differing concerns and objectives for each phase of the overall stability testing program.

ISSN:0363-9045    

DOI:10.3109/03639048409039059

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639048409039060

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

摘要:

AbstractThe organization and implementation of a stability program for marketed batches is addressed by answering the questions: (1) What is a stability program?, (2) Why are stability programs necessary?, and (3) How do we conduct the program? Comments will be made regarding historical considerations and remarks will be directed toward the tools that are necessary for the program. There is no documented cookbook describing how to organize and perform your stability program. There are indications however, and these will be incorporated into a discussion of how one program is being used.

ISSN:0363-9045    

DOI:10.3109/03639048409039061

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639048409039062

出版商:Taylor&Francis    

年代:1984

数据来源: Taylor